| CTRI Number |
CTRI/2025/08/092921 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Proprioceptive training protocol combined with kinesiotaping to improve balance in cerebral palsy children using pediatric balance scale |
|
Scientific Title of Study
|
Proprioceptive training regimen combined with kinesio taping to improve balance in spastic diplegic children using pediatric balance scale a cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal ankush rathod |
| Designation |
Graduate student |
| Affiliation |
Dr ulhas patil college of physiotherapy jalgaon |
| Address |
Dr ulhas patil college of physiotherapy khirdi shivar bhusawal jalgaon road Dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road Jalgaon MAHARASHTRA 425507 India |
| Phone |
8329465312 |
| Fax |
|
| Email |
snehalrathod637@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Krutika ishwar kale |
| Designation |
Professor |
| Affiliation |
dr ulhas patil college of physiotherapy jalgaon |
| Address |
NH 06, Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon Maharashtra 425507 India NH 06, Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon Maharashtra 425507 India Jalgaon MAHARASHTRA 425507 India |
| Phone |
9146890653 |
| Fax |
|
| Email |
kkrutikaa45@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
snehal ankush rathod |
| Designation |
Graduate student |
| Affiliation |
dr ulhas patil college of physiotherapy jalgaon |
| Address |
dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road NH 06, Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon Maharashtra 4250001 India Jalgaon MAHARASHTRA 425507 India |
| Phone |
08329465312 |
| Fax |
|
| Email |
snehalrathod637@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr ulhas patil college of physiotherapy jalgaon maharashtra 425309 |
|
|
Primary Sponsor
|
| Name |
Dr krutika kale |
| Address |
Dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road 425507 maharashtra |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Drsnehal ankush rathod |
dr ulhas patil college of physiotherapy jalgaon |
physiotherapy department opd no 207 dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road Jalgaon MAHARASHTRA |
08329465312
snehalrathod637@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (2) ICD-10 Condition: F82||Specific developmental disorder ofmotor function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
proprioception exercises |
1. Children having 6-12 years of age and who were clinically diagnosed with Spastic diplegic cerebral palsy were included in the study.
2. Prior consent was taken from their respective guardians and all their concerns and queries were respectfully answered.
3. The warm-up phase will last for 5 min and include the following exercises, each session lasted 40 min and followed the list of 6 exercises that we recommended in the exact order they are listed, from 1 to 6 , starting with
• Taping protocol (5 Min)
• Warm-up (5 Min)
• Proprioceptive training (20 Min)
• Cool-down (5 Min)
4. Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed as spastic diplegic cerebral palsy
Age between 6 to 12 years
Both gender
Gross motor function level 1and 2
Written consent from their parents
Spasticity range between 1 and 1+ grade according Modified Ashworth scale in Gastrosoleus muscle.
|
|
| ExclusionCriteria |
| Details |
Uncooperative childrens
Unstable medical conditions epilepsy cardiovascular disease
Sensory processing disorders that may interfere with taping interventions
Recent surgery or injury affecting mobility
Recent Fracture
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pediatric Balance Scale
|
4.Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Gross Motor Function Classification System |
Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
|
| 3. Modified Ashworth Scale |
Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
|
|
|
Target Sample Size
|
Total Sample Size="11" Sample Size from India="11"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="28" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM
To
investigate the effectiveness of a proprioceptive training regimen
combined
with kinesiotaping to improve balance in spastic diplegic childrens.
OBJECTIVE 1) To
analyze balance in spastic diplegic children’s using peadiatric balance scale.
2) To
improve balance in spastic diplegic children’s by proprioceptive training
regimen combined with kinesiotaping using pediatric balance scale. 3) To
enhance balance in children with spastic diplegia, a 4 week protocol combining
proprioceptive training and kinesiotaping was implemented, assessed using the
pediatric balance scale. Procedure 1. All
participants will be screened as per the inclusion and exclusion criteria.
2. A
written informed consent will be taken from their parents.
3. Demographic
information will be collected of all participants.
4. GMFCS
will be administered and only Level 1 and Level 2 Cerebral Palsy children will be selected
5. Modified
ashworth scale will be taken for assesing spasticity in gastrosoleus
muscle & pediatric balance score to
assess balance in participant pre intervention
6. Implement
proprioceptive training regimen combined with tapping (4 week interventions
7. MAS
will be taken for assesing spasticity in gastrosoleus muscle & pediatric balance score to assess
balance in participant post intervention
8. The
collected data will be analyzed by using statistical tests and results will be
generated Intervention
- Children having 6-12 years of age
and who were clinically diagnosed with Spastic diplegic cerebral palsy
were included in the study.
- Prior consent was taken from their
respective guardians and all their concerns and queries were respectfully
answered.
- The warm-up phase will last for 5
min and include the following exercises, each session lasted 40 min and
followed the list of 6 exercises
that we recommended in the exact order they are listed, from 1 to 6, starting with , Taping protocol (5 Min)
Warm-up (5 Min)
Proprioceptive training (20 Min) Cool-down (5 Min) 1. 4 Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session
lasted for 40 Mins .
|